Director, QC Product Readiness
$210.38k - $272.25kGilead
At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.
Job DescriptionCompany Overview
Gilead Sciences Inc. is a biopharmaceutical company committed to advancing innovative medicines that help prevent and treat life-threatening diseases. Our work is grounded in scientific rigor collaboration accountability and a shared commitment to improving the lives of patients.
Position Overview
The Director Quality Control Product Readiness leads the organization of QC Leads responsible for assigned commercial products and programs. The role establishes direction governance expectations and resource priorities for the QC Lead function ensuring consistent oversight of product readiness analytical lifecycle activities and transition from clinical to commercial QC. This leader coaches and develops the QC Leads removes barriers resolves cross-program issues and serves as the escalation point in commercial QC.
Focus Areas
Product Readiness and Portfolio Execution
- Oversee clinical-to-commercial QC transitions and ongoing product readiness ensuring clear criteria stakeholder alignment sustainable ownership and resolution of readiness gaps.
- Manage portfolio priorities testing capacity resources and execution risks; escalate systemic issues and sponsor recovery plans to support uninterrupted product supply.
- Analytical and Regulatory Lifecycle Oversight
- Provide technical guidance and decision frameworks for complex analytical issues investigations methods specifications reference standards documentation and related readiness gaps.
- Ensure scientifically sound health authority responses and governance of post-approval changes and regulatory commitments through implementation and closure.
Leadership and Cross-Functional Partnership
- Build lead mentor and develop a high-performing team of QC Leads responsible for product readiness and analytical lifecycle oversight.
- Define the QC Lead operating model role expectations decision rights performance standards and development pathways.
- Ensure appropriate assignment and capacity of QC Leads across the portfolio based on program complexity risk and business priorities.
- Establish scalable standards metrics and continuous improvement practices that strengthen consistency product readiness compliance and execution across the QC Lead organization.
- Contribute to department strategy workforce and resource planning budgeting succession planning and long-range capability development.
Qualifications
- BS degree with 12 years of relevant experience MS degree with 10 years of relevant experience or PhD with 2 years of relevant experience in Chemistry Biochemistry Pharmaceutical Sciences Life Sciences or a related field.
- Significant experience in pharmaceutical or biopharmaceutical Quality Control including leadership of technical professionals responsible for commercialization product lifecycle management or external laboratory oversight.
- Demonstrated ability to lead and develop product-focused QC Leads establish governance and operating standards balance portfolio priorities and drive accountability through others.
- Broad technical knowledge of analytical method validation and transfer method lifecycle management commercial specifications laboratory investigations sample management and testing logistics.
- Experience providing leadership oversight for QC-related BLA or NDA content and responses to health authority questions.
- Strong knowledge of cGMP principles data integrity expectations and applicable global regulatory requirements for commercial analytical testing.
- Proven ability to influence senior cross-functional stakeholders resolve complex escalations manage competing portfolio priorities and make risk-based decisions in ambiguous environments.
- Excellent scientific judgment people leadership coaching organizational written communication and presentation skills.
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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections please view the Know Your Rights poster.
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
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